Houston, TX — April 24, 2025 — PolyVascular, a pioneering medical device company developing the first polymer-based transcatheter pulmonary valve designed specifically for young children, announced today that it has been awarded a $3 million Small Business Innovation Research (SBIR) Phase IIb grant from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH). This funding will support clinical study preparations, regulatory submissions and the conduct of PolyVascular’s first-in-human clinical trial.
Congenital heart disease (CHD) is the most common birth defect worldwide, affecting approximately 1 million children annually. Many of these children require pulmonary valve replacement, often through invasive open-heart surgeries using biologic valves that degrade over time and necessitate repeat procedures. PolyVascular’s polymeric valve is designed to be delivered via catheter, reducing the need for repeat open-heart surgeries, and is engineered to accommodate growth, reducing the frequency of future interventions.
“This grant represents a critical milestone in our mission to transform pediatric heart care,” said Dr. Daniel Harrington, Co-Founder of PolyVascular. “Our polymer-based valve is tailored for small children and offers a minimally invasive, durable solution that can grow with the patient, potentially reducing the number of surgeries over a child’s lifetime.”
The company’s valve features a tri-leaflet polymer design mounted within a metal stent in a size suitable for children as young as two years old. The balloon expandable stent enables precise sizing and redilation as the child grows. Unlike traditional biologic valves, the polymeric design avoids immune-related degradation and offers improved durability. Preclinical studies have demonstrated promising performance, and the new funding will support regulatory submissions and the early feasibility study.
This grant is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award Number R44HL129577. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
PolyVascular has previously secured over $5 million in non-dilutive funding, including prior SBIR Phase I and II grants, as well as a $2 million grant from CobiCure Medical Technologies. The company anticipates initiating its first human clinical trial in early 2026.
“We are grateful for the continued support from the NIH and our partners,” said Dr. Henri Justino, CEO and Co-Founder of PolyVascular. “This funding brings us closer to providing a life-changing solution for children with congenital heart disease and their families.”
About PolyVascular
Founded in 2014, PolyVascular is a Houston-based medical device company developing the first polymer-based transcatheter pulmonary valve designed for pediatric patients. The company’s innovative approach aims to reduce the need for open-heart surgeries and improve long-term outcomes for children with congenital heart disease.
Reaching this important milestone would not have been possible without the steadfast support and collaboration of our partners and champions, including CobiCure, Graeme McDaniel Foundation, Consortium for Technology & Innovation in Pediatrics (CTIP), Impact 1, Southwest National PDC, Alliance for Pediatric Device Innovation (APDI) and our dedicated angel investors. Their belief in our mission has played a critical role in enabling PolyVascular to advance pediatric heart valve technology and secure this transformative NIH grant.
For more information, visit www.polyvascular.com
